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Blood, 20 August 2009, Vol. 114, No. 8, pp. 1489-1497. Prepublished online as a Blood First Edition Paper on June 4, 2009; DOI 10.1182/blood-2009-02-203398. This Article Full Text (PDF) Supplemental Appendix All Versions of this Article: blood-2009-02-203398v1 114/8/1489    most recent e-Letter: Submit a Response Alert me when this article is cited Alert me when e-Letters are posted Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Reece, D. E. Articles by Comenzo, R. L. Search for Related Content PubMed PubMed Citation Articles by Reece, D. E. Articles by Comenzo, R. L. Related Collections Related Article in Blood Online Social Bookmarking                         What's this?  Previous Article  |  Next Article  Submitted February 5, 2009 Accepted May 1, 2009 Weekly and twice-weekly bortezomib in patients with systemic AL-amyloidosis: results of a phase 1 dose-escalation study Donna E. Reece*, Vaishali Sanchorawala, Ute Hegenbart, Giampaolo Merlini, Giovanni Palladini, Jean-Paul Fermand, Robert A. Vescio, Xiangyang Liu, Yusri A. Elsayed, Andrew Cakana, and Raymond L. Comenzo Princess Margaret Hospital, Toronto, ON, Canada Boston University Medical Center, Boston, MA, United States Amyloidosis Center, University of Heidelberg, Heidelberg, Germany Center for Amyloidosis, Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy Hopital Saint Louis, Paris, France Cedars-Sinai Medical Center, Los Angeles, CA, United States Johnson & Johnson Oncology Research & Development, Raritan, NJ, United States Johnson & Johnson Oncology Research & Development, High Wycombe, United Kingdom Memorial Sloan-Kettering Cancer Center, New York, NY, United States * Corresponding author; email: donna.reece{at}uhn.on.ca. New treatment options are required for primary systemic AL-amyloidosis (AL), a protein conformational disorder associated with a clonal plasma cell dyscrasia. This phase 1 dose-escalation component of a phase 1/2 study in relapsed AL aimed to determine the maximum tolerated dose (MTD) of bortezomib once-weekly (0.7-1.6 mg/m2; days 1, 8, 15, 22; 35-day cycles) and twice-weekly (0.7-1.3 mg/m2; days 1, 4, 8, 11; 21-day cycles) and assess preliminary hematologic responses. Thirty one patients with relapsed AL were enrolled across seven cohorts. Dose-limiting toxicity included grade 3 congestive heart failure in two patients (one at once-weekly, 1.6 mg/m2, and one at twice-weekly, 1.0 mg/m2). MTD was not defined for either schedule; the maximum doses of 1.6 mg/m2 (once-weekly) and 1.3 mg/m2 (twice-weekly) are being used in phase 2 evaluation. Most commonly reported toxicities on both schedules included gastrointestinal events, fatigue, and nervous system disorders. Discontinuations and dose reductions for toxicity were reported in 12 and 4 patients, respectively. No treatment-related deaths occurred. Hematologic responses occurred in 15/30 (50%) evaluable patients, including 6 (20%) complete responses. Median time to first response was 1.2 months. Once-weekly and twice-weekly bortezomib appear generally well tolerated in relapsed AL, with promising hematologic responses. This study is registered with ClinicalTrials.gov under identifier NCT00298766. CiteULike    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this? Related Article in Blood Online: Finishing off fibrils Morie Gertz Blood 2009 114: 1456-1457. [Abstract] [Full Text] [PDF] This article has been cited by other articles: R. Specter, V. Sanchorawala, D. C. Seldin, A. Shelton, S. Fennessey, K. T. Finn, J. B. Zeldis, and L. M. Dember Kidney dysfunction during lenalidomide treatment for AL amyloidosis Nephrol. Dial. Transplant., August 5, 2010; (2010) gfq482v1. [Abstract] [Full Text] [PDF] M. A. Gertz I don't know how to treat amyloidosis Blood, July 29, 2010; 116(4): 507 - 508. [Full Text] [PDF] S.-C. Hsiao, M.-C. Wang, H. Chang, and S.-N. Pei Recurrent Capillary Leak Syndrome Following Bortezomib Therapy in a Patient with Relapsed Myeloma Ann. Pharmacother., March 1, 2010; 44(3): 587 - 589. [Abstract] [Full Text] [PDF] R. L. Comenzo How I treat amyloidosis Blood, October 8, 2009; 114(15): 3147 - 3157. [Abstract] [Full Text] [PDF] Bortezomib for Systemic Amyloidosis Journal Watch Oncology and Hematology, September 29, 2009; 2009(929): 1 - 1. [Full Text] M. Gertz Finishing off fibrils Blood, August 20, 2009; 114(8): 1456 - 1457. [Abstract] [Full Text] [PDF]

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